Avastin Maker will Contest FDA Decision to Revoke Breast Cancer Approval

Roche, the maker of <"http://www.yourlawyer.com/practice_areas/defective_drugs">Avastin, will contest the US Food & Drug Administration’s (FDA) decision to revoke the pricey cancer drug’s approval as a treatment for advanced breast cancer. According to a report on inpharm.com, Roche, a subsidiary of Genentech, will utilize a little-used protocol that allows a public hearing in order to challenge the FDA’s Avastin decision.

Avastin, the best selling cancer drug in the world, was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. It was originally approved in 2004 to treat metastatic colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer. In 2008, the FDA also approved Avastin as a metastatic breast cancer treatment in combination with a chemotherapy drug called paclitaxel, and in 2009, it was approved to treat kidney cancer, as well as glioblastoma multiforme, an incurable brain cancer.

Avastin is one of the most expensive drugs on the market, costing between $50,000 and $100,000 a year. In fact, many patient advocates have criticized the high cost, because Avastin neither cures cancer nor significantly prolongs life.

When the FDA approved Avastin to treat metastatic breast cancer in 2008, it did so against the recommendation of its advisory panel. Avastin for breast cancer was approved under the FDA’s accelerated approval program, based on initial positive studies. Companies then have to submit additional data to gain full approval. Avastin’s provisional approval for breast cancer was based on an initial trial that showed it lengthened the time until the disease worsened, though it did not prolong the women’s lives by a statistically significant amount.

Earlier this year results from four new trials that enrolled more than 3,000 women found no significant reduction in disease progression or death among those who took Avastin along with chemotherapy. In July, after reviewing all available data, an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.

Last week, the FDA said it was recommending that the advanced breast cancer indication for the pricey cancer drug be revoked after reviewing the results of four clinical studies of Avastin in women with breast cancer. The agency said it determined that the data indicate that the Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

The FDA’s decision on Avastin for breast cancer does not affect the drug’s indication for other cancers.

Roche disagrees with the FDA’s breast cancer decision, according to the inpharm.com report. Hal Barron chief medical officer and head of global product development at Roche, said: “We believe women living in the United States with metastatic HER2-negative breast cancer should […] have Avastin as a treatment option, and, therefore, we will request a hearing with the FDA.”

Until that hearing is concluded, Avastin will retain its indication as a treatment for advanced breast cancer.

The FDA’s decision on Avastin has stirred debate in some quarters. The Susan G. Komen Race for the Cure, for example, has asked that insurers continue to cover Avastin as a breast cancer treatment, and said it was concerned about the potential impact on women who are benefitting from the drug if the FDA ultimately removes its approval for the drug for breast cancer treatment.

“We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it,” the group’s president, Elizabeth Thompson, said in a statement.

The group’s statement also encouraged Genentech/Roche to continue research on a biomarker for Avastin to determine which women will benefit from the drug.

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